A Phase 4 interventional study of Hydroxychloroquine Sulfate Tablets and Placebo Tablets in Coronary Artery Disease, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-27.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate whether treated with hydroxychloroquine could improve therapeutic effect for patients with high-risk coronary artery disease.
This double blind, placebo, randomized controlled trial is going to assess if hydroxychloroquine could improve the high sensitivity C-reaction protein, blood lipid, blood glucose and blood pressure, also whether hydroxychloroquine could affect the secretion of inflammatory cytokines and the M1/M2 phenotype polarization of macrophages in patients with high-risk coronary artery disease.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 35 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects are treated with hydroxychloroquine sulfate tablets.All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
Drug: Hydroxychloroquine Sulfate Tablets
Subjects are treated with placebo tablets. All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
Drug: Placebo Tablets
Subjects are treated with oral hydroxychloroquine sulfate tablets 200mg twice daily for 20 weeks. All the interventions are built on the guideline-based secondary prevention of coronary heart disease medications.
Also known as: Plaquenil
Subjects are treated with oral placebo tablets 200mg twice daily for 20 weeks. All the interventions are built on the guideline-based secondary prevention of coronary heart disease medications.
Also known as: placebo
change of fasting high sensitivity C-reactive protein
Time frame: change from baseline at the 16th week, 39th week, 55th week.
change of blood pressure
Time frame: change from baseline at the 12th week, 20th week.
change of fasting blood lipid
Time frame: change from baseline at the 12th week, 20th week.
change of fasting blood glucose
Time frame: change from baseline at the 12th week, 20th week.
change of fasting insulin
Time frame: change from baseline at the 12th week, 20th week.
change of echocardiogram
Time frame: change from baseline at the 12th week, 20th week.
change of fasting Interleukin 6
Time frame: change from baseline at the 12th week, 20th week.
change of fasting tumor necrosis factor
Time frame: change from baseline at the 12th week, 20th week.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University